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Edoxaban effective in preventing stroke, reducing bleeding and cardiovascular death in patients with atrial fibrillation
Date:11/19/2013

with atrial fibrillation (irregular heart rate) who were at moderate-to-high risk for stroke. The trial was conducted at 1,393 centers in 46 countries. Participants were enrolled from November 2008 to November 2010.

Patients had an equal chance to receive warfarin, high-dose edoxaban (60 milligrams/day), or low-dose edoxaban (30 milligrams/day), although knowledge of which treatment they were assigned was not revealed until after the end of the study.

About one-quarter of the patients had the dose of edoxaban lowered at the start of the trial based on their individual profile to ensure the desired blood level of the drug. To ensure patients treated with warfarin had the proper degree of blood-thinning, blood tests were performed at least monthly in each group, although such testing is not necessary with edoxaban.

The primary goals of the study were to assess the combined outcome of stroke or systemic embolism (primary efficacy outcome), as well as bleeding.

During the treatment period, the rate of stroke or systemic embolism was 1.50 percent per year for participants on warfarin, and 1.18 percent per year for those on high-dose edoxaban. This represents a 21 percent reduction in the risk of stroke or systemic embolism with high-dose edoxaban compared to warfarin.

Moreover, annualized rates of major bleeding were 3.43 percent with warfarin and 2.75 percent with high-dose edoxaban, representing a 20 percent reduction in bleeding. There were also fewer cardiovascular deaths with edoxaban compared to warfarin: high-dose edoxaban 2.74 percent per year compared to warfarin 3.17 percent per year.

The favorable results with edoxaban were achieved despite excellent management with warfarin in this study (blood tests were in range more than two-thirds of the time, a higher rate than that seen in other similar studies).

Future research with edoxaban will investigate if patients with other conditions treated
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Contact: Marjorie Montemayor-Quellenberg
mmontemayor-quellenberg@partners.org
617-525-6383
Brigham and Women's Hospital
Source:Eurekalert  

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Edoxaban effective in preventing stroke, reducing bleeding and cardiovascular death in patients with atrial fibrillation
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